Side EffectsSide Effects

Side Effects

Understanding Possible Side Effects of IMBRUVICA® (ibrutinib)

IMBRUVICA® may cause serious side effects, including1:

  • Bleeding problems (hemorrhage)
  • Infections
  • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter), heart failure and death
  • High blood pressure (hypertension)
  • Decrease in blood cell counts
  • Second primary cancers
  • Tumor lysis syndrome (TLS)*

*TLS is a disorder caused by the breakdown products of cancer cells, which can lead to kidney failure and other abnormalities.

The most common side effects of IMBRUVICA in adults or children 1 year of age and older with cGVHD include1:

  • Tiredness
  • Muscle spasms
  • Low red blood cell count (anemia)
  • Mouth sores (stomatitis)
  • Bruising
  • Bleeding
  • Diarrhea
  • Nausea
  • Low platelet count
  • Stomach pain
  • Muscle and joint pain
  • Pneumonia
  • Fever
  • Headache

In the adult and pediatric cGVHD clinical trials, nearly 1 in 4 of patients stopped taking IMBRUVICA® because of side effects.1

This is not a complete list of side effects. Others may occur. Tell your doctor if you think you are experiencing side effects.

If you are having some side effects, your doctor may tell you to lower your dose or to stop taking IMBRUVICA®. That’s one reason it’s so important to tell your healthcare team about side effects at any point in your treatment.1

Helpful tips for cGVHD patients taking IMBRUVICA®

You may experience side effects while taking IMBRUVICA®.1 The suggestions below may help you while on IMBRUVICA®. Talk to your healthcare provider if you think you are experiencing any side effects.

To help with diarrhea2:

Diarrhea can be an uncomfortable side effect for patients taking IMBRUVICA®. It can also be a sign your cGVHD is getting worse.3 So be sure to contact your doctor right away if you develop this symptom. In the meantime, there are also some tips that can help you manage your condition:

  • Stay hydrated. Drink fluids such as water, decaffeinated tea, and clear broth
  • Eat small meals often, and avoid very hot or spicy foods
  • Avoid greasy foods, bran, raw fruits and vegetables, and caffeine
  • Avoid alcohol and tobacco

Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

To help reduce tiredness4:

  • Balance periods of light movement with periods of rest
  • Get plenty of sleep, which may include short naps
  • Remain well hydrated throughout the day
  • Eat a well-balanced diet

To help prevent infection5:

  • Wash hands often and bathe every day
  • Avoid crowds and individuals with contagious diseases
  • Do not keep fresh flowers or live plants in your living space
  • Do not clean droppings from your pets; have someone do this for you

Infection is a serious possible side effect of IMBRUVICA®. Notify a healthcare professional immediately if signs of infection (eg, fever, chills, weakness, and confusion) occur.1

References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2American Cancer Society. Getting help with diarrhea. Accessed August 23, 2022. https://www.cancer.org/content/dam/cancer-org/cancer-control/en/booklets-flyers/getting-help-for-diarrhea.pdf 3Choi SW, Levine JE, Ferrara JL. Pathogenesis and management of graft versus host disease. Immunol Allergy Clin North Am. 2010;30(1):75-101. 4American Cancer Society. Managing cancer-related fatigue at home. Accessed August 23, 2022. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/managing-fatigue-at-home.html 5American Cancer Society. Preventing infections in people with cancer. Accessed August 23, 2022. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/infections/preventing-infections-in-people-with-cancer.html

From the moment you’re prescribed IMBRUVICA®, IMBRUVICA® By Your Side provides resources and support for getting the help you may need during treatment.

Coverage and Cost

Confirm your coverage and out-of-pocket costs for IMBRUVICA®.

Support Communications

Receive periodic emails with tips and information about treatment.

IMBRUVICA® By Your Side Ambassadors*

Call a By Your Side Ambassador if you have questions about IMBRUVICA®.

*By Your Side Ambassadors are provided by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie Company, and do not work under the direction of your healthcare professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.

Pharmacyclics, an AbbVie Company, may collect your personal data through your online and offline interactions with us, including your contact, demographic, geolocation, and health-related data. We may also collect your online usage data automatically through cookies and similar technologies. We use this data for several purposes, such as to provide you with and improve our programs, services, and products, customize your experiences, and for research and analytics. We retain your personal data for as long as necessary to fulfill these purposes or to comply with our record retention obligations. We do not sell your personal data but may use and disclose your personal data with marketing and advertising partners to deliver you ads based on your interests inferred from your activity across other unaffiliated sites and services (“online targeted advertising”) and for website analytics. To opt out of the use or disclosure of your personal data for online targeted advertising or for website analytics, go to Your Privacy Choices on our website. For more information on the personal data categories we collect, the purposes for their collection, our disclosures to third parties, your data subject rights, and our data retention criteria, visit our Privacy Notice.

Through my submission of the program enrollment form, I consent to the collection, use, and disclosure of my personal health data, as described in the Privacy Notice above and in AbbVie’s Privacy Notice in the How We May Disclose Personal Data section. My consent is required to process sensitive personal data under certain privacy laws, and I have the right to withdraw my consent by visiting Your Privacy Choices on AbbVie’s website.

IMBRUVICA® (ibrutinib) is covered by U.S. Patents, which are listed in FDA's Orange Book (available at
https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm).